Senior Manager of Regulatory Affairs Pharmaceutical Chemistry, Manufacturing and Controls
The Company – Syner-G Pharma Consulting, LLC:
- A young, dynamic, entrepreneurial, and growing regulatory and technical consulting firm providing specialized consulting and contracting services in the areas of Chemistry, Manufacturing and Controls (CMC) for biopharmaceutical companies (small molecule and biologic products)
- Adept in developing risk-based CMC strategies following cGMP for 21st Century initiatives and Quality by Design (QbD) principles
- Distinguish ourselves by our passion for creativity and innovation
- Offer flexible work environment allows for on-site, off-site, and virtual-office scenarios
- Clients include national and multinational pharmaceutical companies
The Candidate:
Syner-G Pharma, CMC Consulting is seeking an exceptional science professional to join our Regulatory Affairs team. The candidate will be responsible for supporting our Biotechnology/Pharmaceutical clients throughout the regulatory filing process, including serving as the client lead as Senior Manager of Regulatory Affairs. A successful candidate will have a proven track record of learning and applying scientific principles to solve CMC technical and project management challenges. Seeking a passion to help patients by enabling the expeditious development and approval of high-quality, life-saving medicines.
Required Activities/Experience:
- MS in Chemistry, Biology, Chemical Engineering, Pharmacy, Healthcare, Public Health, or a related field.
- 7+ years’ experience in the Authoring and review of CMC sections for NDA, BLA, IND, and IMPD
- Creation and authoring of global and regional dossiers (IND, IMPD, and Canadian QOS).
- Coordinate timely & accurate assembly of responses to inquiries from the FDA on CMC content
- Strategize regulatory CMC pathway for new small & large molecules
- Assess and strategize post-approval changes and relevant submission
- Authoring CMC amendments, supplements, and annual reports
- Preparing briefing documents for the health authority meetings
- Regulatory agency meeting support including meeting preparation and briefing document creation.
- Review of analytical test methods, specifications, and stability protocol/report/data
- Support and prepare other CMC ad-hoc requests at the pre & post-approval stage of the product
- Coordinate timely & accurate assembly of responses to inquiries from the FDA on CMC content
- Sponsor consultancy regarding drug development including timeline management
Critical success factors:
- Ability to work with diverse stakeholders, both internally and at commercial contract manufacturers.
- Strong knowledge and demonstrated practice of cGMP.
- Detail-oriented with strong written and oral communication skills and proven history of working with others in a multidisciplinary team environment.
- Ability to troubleshoot problems, work within a team, and independently design, develop, and execute experiments.
- Ability to manage several projects simultaneously, creative in developing strategies for solving problems, and is driven by project requirements such as milestones and timelines.
Job Category: Manager
Job Type: Full Time